MECTACER BIOLOX DELTA FEMORAL BALL HEAD

Description of Event or Problem

REVISION SURGERY DUE TO INFECTION AFTER ABOUT 2 YEARS AND 6 MONTHS FROM PRIMARY.THE SURGEON PERFORMED A WASHOUT, I&D, AND REVISED THE 40MM BIOLOX HEAD M TO A 40MM BIOLOX OPTION HEAD WITH SLEEVE, AND REVISED THE FLAT PE HC LINER D 40/G TO A SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 01 JULY 2026 MECTACER 01.29.213 MECTACER HEAD BIOLOX DELTA DIA.40 12/14-M (K112115) LOT. 2337701: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-OCT-2023. EXPIRATION DATE: 2028-SEP-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. MPACT 01.32.4052HCT FLAT PE HC LINER D 40/G (K103721) LOT. 2217707: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-SEP-2022. EXPIRATION DATE: 2027-SEP-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ROOT CAUSE:INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.